Traditional Chinese Medicine Compound (Tongxinluo) and Clinical Outcomes of Patients With Acute Myocardial Infarction: The CTS-AMI Randomized Clinical Trial
Authors' conclusion
In patients with STEMI, the Chinese patent medicine Tongxinluo, as an adjunctive therapy in addition to STEMI guideline-directed treatments, significantly improved both 30-day and 1-year clinical outcomes.
Study context
- Population
- Patients with STEMI within 24 hours of symptom onset, China, 2019–20203,777 in primary analysis
- Participants
- 3,797 patients
- Comparison
- Tongxinluo vs placebo, added to STEMI guideline-directed treatment
- Tongxinluon = 1,889
- Placebon = 1,888reference
- Primary endpoint
- MACCE:
- Cardiac death
- Myocardial reinfarction
- Emergent coronary revascularization
- Stroke
- Follow-up
- 30 days
Methodological detailsdouble-blind, placebo-controlled, 124 hospitals in China
- Double-blind
- Placebo-controlled
- 124 hospitals in China
Primary result
As reported in the abstract
Each group vs placeboRelative risk (95% CI)
Tongxinluo
0.64(0.47–0.88)
Each group vs placeboRisk difference (95% CI)
Tongxinluo
−1.8%(−3.2% to −0.6%)
Secondary outcomes
| Outcome | Tongxinluo | Placebo | Estimate | |
|---|---|---|---|---|
| Cardiac death · 30 days | 3.0% | 4.2% | RR 0.70 (95% CI 0.50–0.99) | |
| MACCE · 1 year | 5.3% | 8.3% | HR 0.64 (95% CI 0.49–0.82) | |
| Cardiac death · 1 year | 4.5% | 6.1% | HR 0.73 (95% CI 0.55–0.97) | |
| 0.512Ratio (log scale) |
| Outcome | Risk difference (95% CI) | |
|---|---|---|
| Cardiac death · 30 days | −1.2% (−2.5% to −0.1%) | |
| MACCE · 1 year | −3.0% (−4.6% to −1.4%) | |
| Cardiac death · 1 year | −1.6% (−3.1% to −0.2%) | |
| −6−4−202Difference (linear scale) |
30-day stroke, 1-year all-cause mortality
- No significant differences
Safety
Adverse drug reactions (mainly gastrointestinal symptoms)
P = 0.02
Major bleeding (30 days, 1 year); in-stent thrombosis (<24 hours; 1-30 days; 1-12 months)
- No significant differences
Original publication
Traditional Chinese Medicine Compound (Tongxinluo) and Clinical Outcomes of Patients With Acute Myocardial Infarction: The CTS-AMI Randomized Clinical Trial. JAMA. Published 24 October 2023. doi:10.
Summarised from the published abstract; every number is checked against it